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Reduction of Spontaneous Prematurity by Antibiotic Treatment (Josamycin) (PREMYC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00718705
Recruitment Status : Completed
First Posted : July 21, 2008
Last Update Posted : December 29, 2011
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE July 17, 2008
First Posted Date  ICMJE July 21, 2008
Last Update Posted Date December 29, 2011
Study Start Date  ICMJE July 2008
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2008)
Premature birth [ Time Frame: between 22 and 37 completed weeks of pregnancy. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2008)
  • Antenatal :occurence of a miscarriage late [ Time Frame: between 16 and 22 weeks of amenorrhoea ]
  • Antenatal : premature delivery [ Time Frame: at week of amenorrhea <= 34, 32, 28 ]
  • Antenatal : hospitalisation for risk of premature delivery [ Time Frame: antenatal period ]
  • antenatal : Number of day of hospitalisation for risk of premature delivery [ Time Frame: antenatal period ]
  • Antenatal : premature rupture of membranes [ Time Frame: before 37 week of amenorrhea ]
  • Antenatal : occurence of chorioamnionitis defined by 2 of the following criteria :maternal temperature > 38°C, uterine contractions, Fetid leucorrhoeas, foetal tachycardia > 160bpm, C reactive protein >10mg/l [ Time Frame: antenatal period ]
  • During childbirth : Hyperthermia > 38°C [ Time Frame: Childbirth period ]
  • During childbirth : fetal tachycardia > 160 bpm [ Time Frame: childbirth period ]
  • Post-partum : Hyperthermia > 38°C for more than 24hours [ Time Frame: post partum period ]
  • Post partum :need an antibiotic treatment for more than 48 hours [ Time Frame: post partum period ]
  • Neonatal : neonatal mortality late [ Time Frame: from day 7 to day 28 ]
  • Neonatal : early neonatal mortality [ Time Frame: from day 0 to day 6 ]
  • Neonatal morbidity : immediate neonatal state [ Time Frame: neonatal period ]
  • Neonatal morbidity : infection [ Time Frame: neonatal period ]
  • Neonatal morbidity : respiratory disease [ Time Frame: neonatal period ]
  • Neonatal morbidity : digestive disease [ Time Frame: neonatal period ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2008)
  • Antenatal :occurence of a miscarriage late [ Time Frame: between 16 and 22 weeks of amenorrhoea ]
  • Antenatal : premature delivery [ Time Frame: at week of amenorrhea <= 34, 32, 28 ]
  • Antenatal : hospitalisation for risk of premature delivery [ Time Frame: antenatal period ]
  • antenatal : Number of day of hospitalisation for risk of premature delivery [ Time Frame: antenatal period ]
  • Antenatal : premature rupture of membranes [ Time Frame: before 37 week of amenorrhea ]
  • Antenatal : occurence of chorioamnionitis defined by 2 of the following criteria :maternal temperature > 38°C, uterine contractions, Fetid leucorrhoeas, foetal tachycardia > 160bpm, C reactive protein >10mg/l [ Time Frame: antenatal period ]
  • During childbirth : Hyperthermia > 38°C [ Time Frame: Childbirth period ]
  • During childbirth : fetal tachycardia > 160 bpm [ Time Frame: childbirth period ]
  • post-partum : • Hyperthermia > 38°C for more than 24hours [ Time Frame: post partum period ]
  • Post partum :need an antibiotic treatment for more than 48 hours [ Time Frame: post partum period ]
  • Neonatal : neonatal mortality late [ Time Frame: from day 7 to day 28 ]
  • Neonatal : early neonatal mortality [ Time Frame: from day 0 to day 6 ]
  • Neonatal morbidity : immediate neonatal state [ Time Frame: neonatal period ]
  • Neonatal morbidity : infection [ Time Frame: neonatal period ]
  • Neonatal morbidity : respiratory disease [ Time Frame: neonatal period ]
  • Neonatal morbidity : digestive disease [ Time Frame: neonatal period ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Reduction of Spontaneous Prematurity by Antibiotic Treatment (Josamycin)
Official Title  ICMJE Reduction of Spontaneous Prematurity: Impact of Antibiotic Treatment (Josamycin) in Case of Positive PCR for Ureaplasma Spp and/or Mycoplasma Hominis in Amniotic Fluid
Brief Summary The purpose of this study is to test the effectiveness of an antibiotic treatment (Josamycin) in the case of positive PCR for Ureaplasma spp. and/or Mycoplasma hominis in the second quarter on the risk of premature birth.
Detailed Description

Infection would be the cause of 40 % of spontaneous premature deliveries. The physiopathological hypothesis accepted is a premature ascent of present bacteria in the low genital ways towards the decidual, the foetal membranes then the amniotic liquid. These bacteria are responsible for an inflammatory reaction to the interface feto-maternal characterized by the production of proinflammatory cytokines and pro-contractants agents (prostaglandins, oxytocin) by the decidual and the membranes.

These mediators cause uterine contractions, a maturation of the uterine collar, a rupture of the membranes then a premature birth.

Several recent publications show on the one hand that Mycoplasma hominis and Ureaplasma spp. are the bacteria most frequently found in the amniotic liquid in the second quarter of the pregnancy and that a positive PCR for these bacteria is associated with a premature birth.

A probable assumption would be that Mycoplasma hominis or Ureaplasma spp. cause a premature birth by infecting the fetal membranes and the decidual, then activating the immune system and the pro-inflammatory production of cytokines. These bacteria are sensitive to antibiotic treatment.

Nevertheless, no randomized controlled trials have been carried out to determine wether an antibiotic treatment would decrease spontaneous prematurity in the case of positive PCR in the amniotic liquid.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Prematurity
Intervention  ICMJE
  • Drug: Josamycin
    josamycin with posology of 2 grams per day by oral way during 10 days
  • Drug: Placebo
    Placebo with posology of 2 grams per day by oral way during 10 days
Study Arms  ICMJE
  • Experimental: 1
    josamycin
    Intervention: Drug: Josamycin
  • Placebo Comparator: 2
    Placebo
    Intervention: Drug: Placebo
Publications * Kayem G, Doloy A, Schmitz T, Chitrit Y, Bouhanna P, Carbonne B, Jouannic JM, Mandelbrot L, Benachi A, Azria E, Maillard F, Fenollar F, Poyart C, Bebear C, Goffinet F. Antibiotics for amniotic-fluid colonization by Ureaplasma and/or Mycoplasma spp. to prevent preterm birth: A randomized trial. PLoS One. 2018 Nov 7;13(11):e0206290. doi: 10.1371/journal.pone.0206290. eCollection 2018.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 18, 2008)
3200
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2011
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient older ≥ 18 years
  • French speaking
  • Women who have an amniocentesis between 15 and 20 weeks of amenorrhoea for an antenatal diagnosis
  • Affiliated to social security or an equivalent system
  • Karyotype analysis and ultrasound morphological normal (apart from minor signs of trisomy 21)
  • Clear amniotic fluid (not contaminated by the mother's blood)
  • Gestational age is between 15 WA(day+0) and 20 WA(day+6)
  • Patient have not allergy to macrolides
  • Do not have cure underway by macrolide
  • Patient followed during her pregnancy in an investigator site
  • Informed consent and signed

Exclusion Criteria:

  • No speaking french
  • Having an allergy to macrolides
  • Having a multiple pregnancy
  • Morphological Anomaly
  • Patient no consented
  • Lactose Intolerance
  • Not agreed to participate
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00718705
Other Study ID Numbers  ICMJE P060216
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Bayer
Investigators  ICMJE
Principal Investigator: Gilles KAYEM Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP